6.1 Clinical Study Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a 12-month randomized, double-blind, parallel group, placebo-controlled study, a total of 309 postmenopausal women were randomized to receive either placebo or Vagifem 10 mcg tablets. Adverse events with an incidence of =5% in the Vagifem 10 mcg group and greater than those reported in the placebo group are listed in Table 1.

Table 1: Treatment-Emergent Adverse Events Reported at a Frequency of =5% and More Frequent in Women Receiving Vagifem 10 mcg

Body System

Adverse Event

Treatment

Number (%) of Women

Placebo

N = 103

n (%)

Vagifem

N = 205

n (%)

Body As A Whole

Back Pain

2 (2)

14(7)

Digestive System

Diarrhea

0

11 (5)

Urogenital System

Vulvovaginal Mycotic Infection

3 (3)

17 (8)

Vulvovaginal Pruritis

2 (2)

16 (8)

N = Total number of women in study.

n = Number of women who experienced adverse event.

In a 12-week, randomized, double-blind, placebo-controlled study, 138 postmenopausal women were randomized to receive either placebo or Vagifem 25 mcg tablets. Adverse events with an incidence of =5% in the Vagifem 25 mcg group and greater than those reported in the placebo group are listed in Table 2.

Table 2: Treatment-Emergent Adverse Events Reported at a Frequency of =5% and More Frequent in Women Receiving Vagifem 25 mcg

Body System

Adverse Event

Treatment

Number (%) of Women

Placebo

N = 47

n (%)

Vagifem

N = 91

n (%)

Body As A Whole

Headache

3 (6)

8 (9)

Abdominal Pain

2 (4)

6 (7)

Back Pain

3 (6)

6 (7)

Respiratory System

Upper Respiratory Tract

Infection

2 (4)

5 (5)

Urogenital System

Moniliasis Genital

1 (2)

5 (5)

N = Total number of women in study.

n = Number of women who experienced adverse event.

6.2 Postmarketing Experience

The following adverse reactions have been reported during post approval use of Vagifem 25 mcg. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.